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Post by spiro on Apr 9, 2014 21:27:57 GMT -5
Liane, Baba has been on my watch list along with Harshal, for several weeks now. . Actually, I was very close to sending the boys over to have a little chat with Baba. One more slip up by you and I will have to put you on that list too. To be truthful, a couple of days before the AdCom vote, I had to place myself on the list for a few days.
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Post by spiro on Apr 9, 2014 8:26:00 GMT -5
Now wait a minute, Ashiwi played with the Cricket, I played with the Dreamboat. Investors should not overlook the value that the techosphere pain application has added to potential MNKD worth. i just hope that the FDA will soon relieve my current pain, by approving Afrezza A.S.A.P.
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Post by spiro on Apr 9, 2014 8:13:05 GMT -5
Afrezzamiracle,
thanks for sharing your great letter. Ouch, the truth can hurt at times.
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Post by spiro on Apr 6, 2014 8:40:56 GMT -5
Harsal, daydreaming and irrational exhuberance has not been against the rules on this message board. it is very easy to daydream, when you own stock with a unique product on the verge of FDA approval. I find your Exubera argument amusing. It's much more likely that big pharma understands that Exubera was a much different product, with a poor delivery device and incredibly poor marketing. Pfizer has admitted publicly numerous times that they failed to adequately market and promote Exhubera, which severely limited it's chances for success. Because the cost to develop new drug products from scratch now approaches $5 billion dollars, it would be insane for a major pharma CEO and it's board not to considering making a serious offer for MNKD. When you consider the potential value of Technosphere delivery with a pain and other applications, MNKD's value doubles. I like Rak's proposal of a buyout for Afrezza only for $10-$15 billion, MNKD keeps Afrezza production and pipeline etc. www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/Spiro here, daydreaming in Miami
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Post by spiro on Apr 5, 2014 10:57:55 GMT -5
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Post by spiro on Apr 5, 2014 8:20:43 GMT -5
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Post by spiro on Apr 5, 2014 8:15:34 GMT -5
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Post by spiro on Apr 4, 2014 7:42:15 GMT -5
And the word will spread like wildfire, as diabetics throughout the world learn of Afrezza through the internet, Fox news, OK maybe MSNBC too, family, friends, Superbowl ads and physicians. And then, just when we think things couldn't get any better, MNKD and partner launch the new technosphere cricket device for pain. This is why MNKD will be acquired much sooner than most of you think. BTW, I will allow them to call the new pain device, the " Spiro Cricket ", for a small royalty.
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Post by spiro on Apr 3, 2014 17:55:03 GMT -5
Brentie, it was on the front page for a while, I can't change the link now.
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Post by spiro on Apr 3, 2014 16:24:09 GMT -5
If they said something nice about MNKD, I would even watch MSNBC for a few minutes.
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Post by spiro on Apr 3, 2014 15:37:30 GMT -5
Fox News has a front page story on MNKD. I hope this post doesn't reveal my politics to everyone. www.foxnews.com
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Post by spiro on Apr 3, 2014 7:47:55 GMT -5
Interesting post on YMB yesterday.
broad_and_south • Apr 2, 2014 8:20 AM
Successful AdCom I was at the AdCom yesterday and can tell you it was a breathtaking experience. The ebb and flow was palpable and in the end, the good guys won.
The FDA team was visibly depressed at the end. They were so wrapped up in statistics and digging for dirt that they wholly lost sight of the larger picture. The users and doctors told the FDA there is a need for a delivery method for insulin that is not subcutaneous injection. The existing tools to enable diabetics to control their blood sugar are woefully inadequate. Patients fear dying or losing their sight and there is not much they can do about it. Afrezza’s fast acting pharmacokinetics is a much-needed product. The entire AdCom could have been avoided if the FDA had called physician thought leaders and diabetic care groups for their input.
The first sign that the battle was not going to be one sided was when the Committee’s statistician Brittian first spoke. I thought she was going to dive into the biostatistics with the FDA and agree with them that the 171 study was marginal. To my surprise, she said the results were marginal but perhaps the FDA placed too high a non-inferiority standard. She ultimately proved to be an advocate. She got the bigger picture.
Strange fact: the industry representative Mats Rasmussen did not contribute anything to the meeting. Maybe NOVO is negotiating now with Al?
The Committee imposed several pulmonary conditions on the label. I think this will delay PDUFA but not by months.
The FDA has final say and they can issue another CRL. But that is saying they know more than the AdCom presenters. This will not happen. It was like Seattle beating Denver in the Superbowl. Less
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Post by spiro on Apr 2, 2014 18:25:46 GMT -5
Ok guys, now that my optimism has been adequately recharged, I will try to convince everyone that everything is on track for a prompt FDA approval. It's not only that the panel voted overwhelming for approval, but you must consider that most of them made strong statements about the need for more options being available for diabetics. Some of their arguments for approval were actually quite compassionate for AdCom members. For me, the most interesting and exciting part of yesterday's AdCom was the total lack of questioning regarding the technosphere delivery powder. It appears the entire committee basically endorsed technosphere without a challenge. The questions and concerns were clearly focused on Afrezza. It seems as if some of panel didn't know that Afrezza was an insulin. BTW panel, I am not sure some of you realize how difficult even injectable insulin can be in establishing proper dosing. It is my understanding, that if a doctor can convince a patient to start insulin, that most patients could require tweaking of their dosage. I think the FDA should understand that. Now back to technosphere. Is there any doubt that technosphere was the real winner yesterday? It is my opinion that the value of technosphere being used with other drugs may far exceed the value of Afrezza. Believe me here folks, BIG PHARMA knows this. MNKD will either get a partner soon after FDA approval or they will be acquired within month's. Think about it again, techosphere, inert, pain medication dissolves in lungs, active within 5 minutes, no liver toxicity and minimal side effects. Remember, a technosphere pain application or vaccination will not be a daily dosing for a lifetime. It will be used as needed after surgery, migraine or even possibly arthritis pain. Certainly the long term risk profile will be much lower than Afrezza. Because of my infatuation with technosphere, derived mostly from talking to Adriana Leone bay and Jonathan Goldman at the Drug Delivery Conference, along with yesterday's strong endorsement, I have begun accumulating shares again. It appears obvious that our road will continue to be challenging, but now the odds favor us much greater.
Spiro here
I may have to get more counseling from Babaoriley to control my resurgent confidence.
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JPG ?
Apr 2, 2014 5:34:43 GMT -5
Post by spiro on Apr 2, 2014 5:34:43 GMT -5
Say something !
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Post by spiro on Apr 1, 2014 19:05:32 GMT -5
Forget the heart, Liane and BD were the brains that keep this board at great place to visit and share comments.
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